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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD092243 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Interventions promoting optimum motor performance across the lifespan are a priority after a neurological insult such as stroke. The proposed research incorporates smart devices and 3D printing to create a patient-centered rehabilitation device, mRehab. This innovative blend of technology and principles of neuroplasticity can advance standards of practice in healthcare. In this feasibility study, it is hypothesized that individuals with chronic stroke can successfully use the portable rehabilitation unit, mRehab, at home with minimal oversight from the research team. Use of mRehab in a home based setting and functional changes in upper limb movement will be assessed.
Impairments following stroke make it one of the leading causes of disability. Many individuals with stroke do not recover complete function of the upper limb at time of discharge from clinical services. Moreover, early stage improvements may wane following the cessation of formal therapies. Regaining as much upper limb function as possible is important, as even mild impairments are associated with limitations in daily function and lower health-related quality of life. The overarching purpose of this project is to use portable technology, affordable for home use, to provide objective feedback on performance of upper limb motor tasks to individuals with residual deficits following chronic conditions such as stroke. Objective feedback serves to better inform the participant of their progress and actively engage them in their rehabilitation, thus encouraging self-management of rehabilitation. Results from a recent survey shows therapists predominantly provide patients with stroke written home exercise programs at time of discharge from therapies. With this static approach, patients have a limited capacity to evaluate their motor performance and no encouragement to refine their movement. Smartphones were coupled with three-dimensional (3D) printed objects to create a home rehabilitation system, mRehab. The built-in sensors in smartphones and a custom app can quantify characteristics of movement and provide actionable feedback to users during in-home rehabilitation. It was hypothesized that 1) participants with stroke could use mRehab in a home program with minimal oversight and 2) use of mRehab would result in changes in functional movement.
Methodology: A single-subject experimental design with multiple baselines was used. A strength of the single-subject study design is that participants serve as their own control. Each participant had a varying length of the baseline and follow-up periods to establish that the intervention, rather than time, was the primary reason for any observed change in performance. Participants completed baseline measurements, a six-week mRehab home program, and follow-up measurements. Baseline measurements consisted of both in-lab and in-home measurements. Participants attended two lab visits prior to starting the home program to establish baselines on clinical assessments and to learn how to use mRehab. MRehab collected limited preliminary performance data without providing feedback during baseline. Participants then used mRehab in a six week home program receiving feedback on their performance each time they completed practice of an activity. At the completion of the home program participants completed follow up assessments that were similar to the baseline measurements. In addition, usability of mRehab was assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRehab | Experimental | Use of mRehab in a home program completing unilateral and bilateral activities. Participants are able to complete unilateral activities with their paretic arm/hand |
|
| mRehab completing all activities bilaterally | Experimental | Use of mRehab in a home program completing unilateral and bilateral activities. Participantsare can only complete intended unilateral activities using both hands |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRehab | Device | mRehab (mobile Rehab) was created to better support in-home upper limb rehabilitation programs. It incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items (a mug, bowl, key, and doorknob) integrated with a smartphone and an app. The app guides participants through practice of activities of daily living (ADL), for example, sipping from a mug. It can also consistently measure time to complete an activity and quality of movement (smoothness/accuracy) during the performance of ADLs. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data. |
| Measure | Description | Time Frame |
|---|---|---|
| Repetitions Completed for Each Activity in the mRehab Home Program | The total number of repetitions each participant completed for each activity in mRehab during the 6 week home program was recorded. The average total number of repetitions completed for each activity is reported. | 6 week in-home program |
| Time to Complete Activity in the mRehab Home Program | average time to complete an activity in the mRehab home program | last day of the 6 week in home program |
| Average Smoothness Per Activity in the mRehab Home Program | The average smoothness per activity in mRehab on the first day of the 6 week home program. Using the acceleration readings from the inertial measurement unit embedded in the smartphone, a normalized jerk score which is dimensionless, allowing comparisons of movements that vary in duration and/or amplitude, can be computed. There are no set upper bounds for the score, as it is dependent on the smoothness. The minimum score is 0, which would indicate no jerk, or perfectly smooth movement. This measurement provides relative information for each movement as a normal range has not been established for each of the movements in this study. Overall, a lower score indicates smoother movement. | last day of the 6 week in-home program |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test | The Wolf Motor Function Test (WMFT) is used to assess function of the upper extremity. The 17 item version of the WMFT was used. Tasks in the WMFT include tasks that assess gross motor activity (such as lifting hand/arm and placing it on a box), fine motor activity (such as picking up a paper clip) and strength. One timed task is a bilateral task (folding a towel). For timed tasks, participants are given up to 120 seconds to complete the task. If they cannot successfully complete it in that time they are given the max score of 120 seconds. In our papers we only use the timed tasks in the WMFT in our analyses. We report the average time to complete a task in the WMFT. A lower score indicates less time is required to complete the task. |
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Individuals in the intervention all had a history of stroke.
Inclusion Criteria for feasibility study:
Exclusion Criteria for feasibility study:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanne Langan, PT, PhD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Buffalo | New York | 14214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33749608 | Derived | Bhattacharjya S, Cavuoto LA, Reilly B, Xu W, Subryan H, Langan J. Usability, Usefulness, and Acceptance of a Novel, Portable Rehabilitation System (mRehab) Using Smartphone and 3D Printing Technology: Mixed Methods Study. JMIR Hum Factors. 2021 Mar 22;8(1):e21312. doi: 10.2196/21312. | |
| 32706702 | Derived | Langan J, Bhattacharjya S, Subryan H, Xu W, Chen B, Li Z, Cavuoto L. In-Home Rehabilitation Using a Smartphone App Coupled With 3D Printed Functional Objects: Single-Subject Design Study. JMIR Mhealth Uhealth. 2020 Jul 22;8(7):e19582. doi: 10.2196/19582. |
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The final dataset will include self-reported demographic information (such as age and gender) cognitive assessments, motor performance on clinical assessments and data collected during rehabilitation from mRehab.
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The IPD will be provided following acceptance of manuscripts.
Individual participant data (IPD) will be provided for the primary and secondary outcomes of the study. Data will be available in June 2022 and will continue to be available for 2 years, June 2024. The IPD may be accessed by the URL: https://cse.buffalo.edu/\~wenyaoxu/project/mRehab\_Data.xlsx
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| ID | Title | Description |
|---|---|---|
| FG000 | Use of mRehab in a Home Program | mRehab incorporates a task-oriented approach and immediate performance-based feedback and longitudinal data. mRehab consists of 3D-printed household items integrated with a smartphone and an app that guides participants through practice of ADLs. Single subject design with varying lengths of baseline data acquisition and follow-up data acquisition 2 visits to establish baseline Intervention: 6-week in home training program using mRehab 2 visits to establish performance immediately following intervention and 1-3 weeks post. Participants that completed baseline data acquisition, training and follow up were included in the final analyses. If a participant used hand over hand to complete all mrehab activities. Their data was not included in the analyses. |
| FG001 | Use of mRehab in Home Completing All Activities Bilaterally | Participant completed all activities in the six week in home mRehab program bilaterally. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Individuals with stroke that completed baseline analyses and completed all assessments and training unilaterally with their paretic hand/arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Use of mRehab in a Home Program | mRehab incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items integrated with a smartphone and an app. The app guides participants through practice of activities of daily living. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data. Participants included in this group demonstrate the ability to complete mRehab tasks unilaterally. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Repetitions Completed for Each Activity in the mRehab Home Program | The total number of repetitions each participant completed for each activity in mRehab during the 6 week home program was recorded. The average total number of repetitions completed for each activity is reported. | 16 participants with chronic stroke that completed mRehab in-home training with their paretic hand. | Posted | Mean | Standard Deviation | repetitions | 6 week in-home program |
|
10 weeks including in-lab pre-test, 6 week in-home program, and in-lab post-test
Adverse events were monitored, but none were reported/ observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Use of mRehab in a Home Program | mRehab incorporates a task-oriented approach and immediate performance-based feedback and longitudinal data. mRehab consists of 3D-printed household items integrated with a smartphone and an app that guides participants through practice of ADLs. Individuals that completed all outcome measures unilaterally with their paretic arm/hand were included in this group. Single subject design with varying lengths of baseline data acquisition and follow-up data acquisition 2 visits to establish baseline Intervention: 6-week in home training program using mRehab 2 visits to establish performance immediately following intervention and 1-3 weeks post. In total, it took 10 weeks for participants to complete the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeanne Langan | University at Buffalo | 17168292905 | jlangan@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2019 | May 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The purpose of the intervention was to provide proof of concept that it is feasible for individuals with stroke to use mRehab in a home program and to examine if changes in motor function were enhanced following the home program.
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|
| within 1 week of the completion of the in-home program |
| Nine Hole Peg Test | A timed clinical assessment used to measure finger dexterity. Lower times represent better performance. Participants place 9 pegs in 9 holes and then remove the pegs and place them in a container. The stop watch starts when the participant touches the first peg and stops when they place the last peg in the container. If participants could not complete placing the pegs in the holes they were given a score of 300 seconds. | within 1 week of the end of the in-home program |
| Difficulty Rating Scale | A scale used to elicit user opinions on ease of use of the 3D printed objects (mug, bowl, key, and doorknob). It was a 7 point likert scale ranging from Very Difficult to Very Easy. The range was -3 to 3. A score of -3 represented the three-dimensional printed object was very difficult to use and a score of 3 representing the object was easy to use. The scores for the mug, bowl, key and door knob are included in the mean score given below. | within 1 - 3 weeks of the end of the program |
| Systems Usability Scale (SUS) | A reliable tool for measuring usability. The Systems Usability Scale (SUS) consists of 10 questions, each rated on a 5-point Likert scale ranging from Strongly agree to Strongly disagree. The SUS was used to assess the participant's satisfaction with the mRehab system. A higher score represents a more positive perception of the device. A score of 50 would represent the strongest agreement that mRehab is a usable system. A score of 10 would represent the strongest disagreement that mRehab is a usable system. | within 1-3 weeks of completion of home program |
| mRehab Acceptance Questionnaire | The mRehab (mobile Rehab) acceptance questionnaire was designed to assess the participants perception of the mRehab system we designed for this study. The questionnaire is based upon the Technology Acceptance model using a seven-point Likert scale - highly disagree (1) to highly agree (7)- for each question. Participants responded to 16 questions that probed the user's perceception of how they interacted with technology (3 questions) and their perceived usefulness, perceived ease of use, and behavioral intention to use the mRehab system in the future (13 questions). The total score is calculated as the sum of the response to each question. A score demonstrating the participant highly agreed that they would interact with technology and that they found mRehab useful, easy to use and that they would use in in the future would be 112. The minimum total score would be 16 (with a rating of highly disagree for each question). Higher scores would indicate better acceptance/interaction. | within 1-3 weeks of completion of the 6 week in-home program |
| BG001 | Use of mRehab in a Home Program Completing All Activities Bilaterally | Participant completed all activities in data collection and in the six week in home mRehab program bilaterally. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time to complete activity in the mRehab home program | The average time to complete an activity in mRehab on day 1 of the 6 week home program. | Mean | Standard Deviation | seconds |
|
| Average smoothness per activity in the mRehab home program | The average smoothness per activity in mRehab on the first day of the 6 week home program. Using the acceleration readings from the inertial measurement unit in the smartphone, a normalized jerk score which is dimensionless, allowing comparisons of movements that vary in duration and/or amplitude, can be computed. There are no set upper bounds, as the score is dependent on the smoothness. The minimum score is 0, which would indicate no jerk, or perfectly smooth movement. The score provides relative information for each movement, a normal range has not been established for each movement. | Mean | Standard Deviation | jerk score |
|
| Wolf Motor Function Test- Ave time to complete a task over 2 testing sessions using the WMFM | The Wolf Motor Function Test (WMFT) is used to assess function of the upper extremity. The 17 item version of the WMFT was used. Tasks in the WMFT include tasks that assess gross motor activity (such as lifting hand/arm and placing it on a box), fine motor activity (such as picking up a paper clip) and strength. One timed task is a bilateral task (folding a towel). For timed tasks, participants are given up to 120 seconds to complete the task. If they cannot successfully complete it in that time they are given the max score of 120 seconds. We report the average time to complete an activity. | Mean | Standard Deviation | seconds |
|
| Nine hole peg test average time to complete over 2 testing sessions | The participant places 9 pegs into 9 holes and then removes the pegs. The stop watch is started when the patient touches the first peg and stopped when the patient takes out the last peg from the peg hole and places the it in the container. If participants were unable to complete the task of placing all 9 pegs in a hole, they were given a score of 300 seconds. | Mean | Standard Deviation | seconds |
|
| OG001 | Use of mRehab in a Home Program Completing All Activities Bilaterally | Participant completed all activities in data collection and in the six week in-home mRehab program bilaterally. |
|
|
| Primary | Time to Complete Activity in the mRehab Home Program | average time to complete an activity in the mRehab home program | Participants with chronic stroke that completed the mRehab training using their paretic hand. | Posted | Mean | Standard Deviation | seconds | last day of the 6 week in home program |
|
|
|
|
| Primary | Average Smoothness Per Activity in the mRehab Home Program | The average smoothness per activity in mRehab on the first day of the 6 week home program. Using the acceleration readings from the inertial measurement unit embedded in the smartphone, a normalized jerk score which is dimensionless, allowing comparisons of movements that vary in duration and/or amplitude, can be computed. There are no set upper bounds for the score, as it is dependent on the smoothness. The minimum score is 0, which would indicate no jerk, or perfectly smooth movement. This measurement provides relative information for each movement as a normal range has not been established for each of the movements in this study. Overall, a lower score indicates smoother movement. | 16 participants with chronic stroke performing the in-home rehabilitation unilaterally | Posted | Mean | Standard Deviation | jerk score | last day of the 6 week in-home program |
|
|
|
|
| Secondary | Wolf Motor Function Test | The Wolf Motor Function Test (WMFT) is used to assess function of the upper extremity. The 17 item version of the WMFT was used. Tasks in the WMFT include tasks that assess gross motor activity (such as lifting hand/arm and placing it on a box), fine motor activity (such as picking up a paper clip) and strength. One timed task is a bilateral task (folding a towel). For timed tasks, participants are given up to 120 seconds to complete the task. If they cannot successfully complete it in that time they are given the max score of 120 seconds. In our papers we only use the timed tasks in the WMFT in our analyses. We report the average time to complete a task in the WMFT. A lower score indicates less time is required to complete the task. | Participants with chronic stroke that performed mRehab activities unilaterally. | Posted | Mean | Standard Deviation | seconds | within 1 week of the completion of the in-home program |
|
|
|
|
| Secondary | Nine Hole Peg Test | A timed clinical assessment used to measure finger dexterity. Lower times represent better performance. Participants place 9 pegs in 9 holes and then remove the pegs and place them in a container. The stop watch starts when the participant touches the first peg and stops when they place the last peg in the container. If participants could not complete placing the pegs in the holes they were given a score of 300 seconds. | Participants with stroke that participated in a home rehabilitation program using mRehab. | Posted | Mean | Standard Deviation | seconds | within 1 week of the end of the in-home program |
|
|
|
|
| Secondary | Difficulty Rating Scale | A scale used to elicit user opinions on ease of use of the 3D printed objects (mug, bowl, key, and doorknob). It was a 7 point likert scale ranging from Very Difficult to Very Easy. The range was -3 to 3. A score of -3 represented the three-dimensional printed object was very difficult to use and a score of 3 representing the object was easy to use. The scores for the mug, bowl, key and door knob are included in the mean score given below. | Participants with stroke that participated in a 6 week home program using mRehab. | Posted | Mean | Standard Deviation | units on a scale | within 1 - 3 weeks of the end of the program |
|
|
|
| Secondary | Systems Usability Scale (SUS) | A reliable tool for measuring usability. The Systems Usability Scale (SUS) consists of 10 questions, each rated on a 5-point Likert scale ranging from Strongly agree to Strongly disagree. The SUS was used to assess the participant's satisfaction with the mRehab system. A higher score represents a more positive perception of the device. A score of 50 would represent the strongest agreement that mRehab is a usable system. A score of 10 would represent the strongest disagreement that mRehab is a usable system. | Participants with stroke that completed a 6 week home program using mRehab. | Posted | Mean | Standard Deviation | units on a scale | within 1-3 weeks of completion of home program |
|
|
|
| Secondary | mRehab Acceptance Questionnaire | The mRehab (mobile Rehab) acceptance questionnaire was designed to assess the participants perception of the mRehab system we designed for this study. The questionnaire is based upon the Technology Acceptance model using a seven-point Likert scale - highly disagree (1) to highly agree (7)- for each question. Participants responded to 16 questions that probed the user's perceception of how they interacted with technology (3 questions) and their perceived usefulness, perceived ease of use, and behavioral intention to use the mRehab system in the future (13 questions). The total score is calculated as the sum of the response to each question. A score demonstrating the participant highly agreed that they would interact with technology and that they found mRehab useful, easy to use and that they would use in in the future would be 112. The minimum total score would be 16 (with a rating of highly disagree for each question). Higher scores would indicate better acceptance/interaction. | Participants with stroke that used mRehab in a 6 week home program. | Posted | Mean | Standard Deviation | units on a scale | within 1-3 weeks of completion of the 6 week in-home program |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Vertical mug transfer |
|
| Horizontal mug transfer |
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| Simulate sip from mug |
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| Enter phone number |
|
| Quick tap |
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mRehab task horizontal bowl transfer- moving the bowl horizontally |
| t-test, 2 sided |
| =.001 |
Comparing the change in performing a horizontal bowl transfer, the calculated p-value for this activity was .001 |
| Equivalence |
A paired-t test comparing performance of moving the bowl horizontally at the beginning of the 6 week in-home program to the end of the 6 week in-home program. |
| mRehab task vertical mug transfer- moving the mug vertically up and down | t-test, 2 sided | =.003 | Comparing the change in performing a vertical mug transfer, the calculated p-value for this activity was .003 | Equivalence | A paired-t test comparing performance of the vertical mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program. |
| mRehab task horizontal mug transfer- moving the mug horizontally | t-test, 2 sided | =.009 | Comparing the change in performing a horizontal mug transfer, the calculated p-value for this activity was .009 | Equivalence | A paired-t test comparing performance of the horizontal mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program. |
| mRehab task simulate sip- bring mug within one inch of mouth as if taking a drink | t-test, 2 sided | A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program. | =.933 | Equivalence | A paired-t test comparing performance of the simulated sip at the beginning of the 6 week in-home program to the end of the 6 week in-home program. |
| mRehab task enter phone number | t-test, 2 sided | =.136 | Equivalence | A paired-t test comparing performance of entering a phone number at the beginning of the 6 week in-home program to the end of the 6 week in-home program. |
| mRehab task quick tap- tapping a moving object on the phone screen | t-test, 2 sided | =.005 | Equivalence | A paired-t test comparing performance of the quick tap at the beginning of the 6 week in-home program to the end of the 6 week in-home program. |
| Vertical mug transfer |
|
| Horizontal mug transfer |
|
| simulating sipping from mug |
|
mRehab task horizontal bowl- bowl moved horizontally
| t-test, 2 sided |
| .196 |
| Equivalence |
A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program. |
| mRehab task Vertical Mug- Mug moved vertically and then placed on counter | t-test, 2 sided | =.024 | Equivalence | A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program. |
| mRehab task horizontal mug transfer- moving the mug horizontally | t-test, 2 sided | =.038 | Equivalence | A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program. |
| mRehab task simulate sip | t-test, 2 sided | =.306 | calculated p-value greater than .05 | Equivalence | A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program. |